directive 2002/98/ec of the european parliament and of the

Status: EU Directives are being published on this site to aid cross referencing fromUK legislation. After exit day no further amendments will be applied to this version.

Directive 2002/98/EC of the European Parliament and of the Councilof 27 January 2003 setting standards of quality and safety for thecollection, testing, processing, storage and distribution of human

blood and blood components and amending Directive 2001/83/EC

DIRECTIVE 2002/98/EC OF THE EUROPEANPARLIAMENT AND OF THE COUNCIL

of 27 January 2003

setting standards of quality and safety for the collection,testing, processing, storage and distribution of human bloodand blood components and amending Directive 2001/83/EC

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article152(4)(a) thereof,

Having regard to the proposal from the Commission(1),

Having regard to the opinion of the Economic and Social Committee(2),

Having regard to the opinion of the Committee of the Regions(3),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(4), in the lightof the joint text approved by the Conciliation Committee on 4 November 2002,

Whereas:

(1) The extent to which human blood is used therapeutically demands that the quality andsafety of whole blood and blood components be ensured in order to prevent in particularthe transmission of diseases.

(2) The availability of blood and blood components used for therapeutic purposes isdependent largely on Community citizens who are prepared to donate. In order tosafeguard public health and to prevent the transmission of infectious diseases, allprecautionary measures during their collection, processing, distribution and use need tobe taken making appropriate use of scientific progress in the detection and inactivationand elimination of transfusion transmissible pathogenic agents.

(3) The quality, safety, and efficacy requirements of proprietary industrially-preparedmedicinal products derived from human blood or plasma were ensured throughDirective 2001/83/EC of the European Parliament and of the Council of 6 November2001 on the Community code relating to medicinal products for human use(5). Thespecific exclusion of whole blood, plasma and blood cells of human origin from thatDirective, however, has led to a situation whereby their quality and safety, in so faras they are intended for transfusion and not processed as such, are not subject to anybinding Community legislation. It is essential, therefore, that whatever the intendedpurpose, Community provisions should ensure that blood and its components are of

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comparable quality and safety throughout the blood transfusion chain in all MemberStates, bearing in mind the freedom of movement of citizens within Communityterritory. The establishment of high standards of quality and safety, therefore, will helpto reassure the public that human blood and blood components which are derived fromdonations in another Member State nonetheless meet the same requirements as thosein their own country.

(4) In respect of blood or blood components as a starting material for the manufactureof proprietary medicinal products, Directive 2001/83/EC refers to measures tobe taken by Member States to prevent the transmission of infectious diseases,comprising the application of the monographs of the European Pharmacopoeia andthe recommendations of the Council of Europe and the World Health Organisation(WHO) as regards in particular the selection and testing of blood and plasma donors.Furthermore, Member States should take measures to promote Community self-sufficiency in human blood or blood components and to encourage voluntary unpaiddonations of blood and blood components.

(5) In order to ensure that there is an equivalent level of safety and quality of bloodcomponents, whatever their intended purpose, technical requirements for the collectionand testing of all blood and blood components including starting materials for medicinalproducts should be established by this Directive. Directive 2001/83/EC should beamended accordingly.

(6) The Commission's Communication of 21 December 1994 on Blood Safety and Self-sufficiency in the European Community identified the need for a blood strategy inorder to reinforce confidence in the safety of the blood transfusion chain and promoteCommunity self-sufficiency.

(7) In its Resolution of 2 June 1995, on blood safety and self-sufficiency in theCommunity(6), the Council invited the Commission to submit appropriate proposals inthe framework of the development of a blood strategy.

(8) In its Resolution of 12 November 1996 on a strategy towards blood safety and self-sufficiency in the European Community(7), the Council invited the Commission tosubmit proposals as a matter of urgency with a view to encouraging the developmentof a coordinated approach to the safety of blood and blood products.

(9) In its Resolutions of 14 September 1993(8), 18 November 1993(9), 14 July 1995(10), and 17April 1996(11) on blood safety and self-sufficiency through voluntary unpaid donationsin the European Community, the European Parliament stressed the importance ofensuring the highest level of blood safety and has reiterated its continued support forthe objective of Community self-sufficiency.

(10) In elaborating the provisions of this Directive account has been taken of the opinionof the Scientific Committee for Medicinal Products and Medical Devices as well asinternational experience in this field.

(11) The nature of autologous transfusion necessitates a specific consideration in respect ofhow and when to apply the different provisions of this Directive.

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(12) Hospital blood banks are hospital units which perform a limited number of activities,storage, distribution, and compatibility tests. In order to ensure that the quality andsafety of blood and blood components are preserved during the whole transfusion chain,while taking account of the specific nature and functions of hospital blood banks, onlyprovisions relevant to these activities should apply to hospital blood banks.

(13) Member States should ensure that an appropriate mechanism for designating,authorising, accrediting or licensing exists to ensure that the activities of bloodestablishments are performed in accordance with the requirements of this Directive.

(14) Member States should organise inspection and control measures, to be carried out byofficials representing the competent authority, to ensure the compliance of the bloodestablishment with the provisions of this Directive.

(15) Personnel directly involved in the collection, testing, processing, storage anddistribution of blood and blood components need to be appropriately qualified andprovided with timely and relevant training, without prejudice to existing Communitylegislation on the recognition of professional qualifications and on the protection ofworkers.

(16) Blood establishments should establish and maintain quality systems involving allactivities that determine the quality policy objectives and responsibilities andimplement them by such means as quality planning, quality control, quality assurance,and quality improvement within the quality system, taking into account the principlesof good manufacturing practice as well as the EC conformity assessment system.

(17) An adequate system to ensure traceability of whole blood and blood componentsshould be established. Traceability should be enforced through accurate donor, patient,and laboratory identification procedures, through record maintenance, and through anappropriate identification and labelling system. It is desirable that a system is developedin order to enable the unique and unmistakable identification of donations of bloodand blood components in the Community. In the case of blood and blood componentsimported from third countries, it is important that an equivalent level of traceabilitybe ensured by the blood establishments in the stages preceding importation into theCommunity. The same requirements of traceability which apply to blood and bloodcomponents collected in the Community should be ensured in the stages followingimportation.

(18) It is important to introduce a set of organised surveillance procedures to collect andevaluate information on the adverse or unexpected events or reactions resulting from thecollection of blood or blood components in order to prevent similar or equivalent eventsor reactions from occurring thereby improving the security of transfusion by adequatemeasures. To this end a common system of notification of serious adverse events andreactions linked to the collection, processing, testing, storage, and distribution of bloodand blood components should be established in Member States.

(19) It is important that when abnormal findings are reported to the donor, relevantcounselling is also provided.



(20) Modern blood-transfusion practice has been founded on the principles of voluntarydonor services, anonymity of both donor and recipient, benevolence of the donor,and absence of profit on the part of the establishments involved in blood transfusionservices.

(21) All necessary measures need to be taken in order to provide prospective donors ofblood or blood components with assurances regarding the confidentiality of any health-related information provided to the authorised personnel, the results of the tests on theirdonations as well as any future traceability of their donation.

(22) According to Article 152(5) of the Treaty, the provisions of this Directive cannot affectnational provisions on the donations of blood. Article 152(4)(a) of the Treaty states thatMember States cannot be prevented from maintaining or introducing more stringentprotective measures as regards standards of quality and safety of blood and bloodcomponents.

(23) Voluntary and unpaid blood donations are a factor which can contribute to high safetystandards for blood and blood components and therefore to the protection of humanhealth. The efforts of the Council of Europe in this area should be supported andall necessary measures should be taken to encourage voluntary and unpaid donationsthrough appropriate measures and initiatives and through ensuring that donors gaingreater public recognition, thereby also increasing self-sufficiency. The definition ofvoluntary and unpaid donation of the Council of Europe should be taken into account.

(24) Blood and blood components used for therapeutic purposes or for use in medical devicesshould be obtained from individuals whose health status is such that no detrimentaleffects will ensue as a result of the donation and that any risk of transmission ofinfectious diseases is minimised; each and every blood donation should be tested inaccordance with rules which provide assurances that all necessary measures have beentaken to safeguard the health of individuals who are the recipients of blood and bloodcomponents.

(25) Directive 95/46/EC of the European Parliament and the Council of 24 October 1995on the protection of individuals with regard to the processing of personal data and thefree movement of such data(12) requires that data related to the health of an individualbe subject to reinforced protection. However, it covers only personal data and not thatrendered anonymous. This Directive should therefore introduce additional safeguardsto prevent any unauthorised changes to donation registries, or processing records, orthe unauthorised disclosure of information.

(26) The Commission should be empowered to establish technical requirements and adoptany necessary changes thereto and to the Annexes in order to take into account scientificand technical progress.

(27) Setting of technical requirements and adaptation to progress should take into accountthe Council recommendation of 29 June 1998 on the suitability of blood and plasmadonors and the screening of donated blood in the EC(13), relevant recommendationsof the Council of Europe and the WHO as well as indications of relevant Europeaninstitutions and organisations such as the monographs of the European Pharmacopoeia.

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(28) It is necessary that the best possible scientific advice is available to the Community inrelation to the safety of blood and blood components, in particular as regards adaptingthe provisions of this Directive to scientific and technical progress.

(29) Tests should be carried out in conformity with the latest scientific and technicalprocedures that reflect current best practice as defined by, and regularly reviewedand updated through, an appropriate expert consultation process. This review processshould also take due account of scientific advances in the detection, inactivation andelimination of pathogens which can be transmitted via transfusion.

(30) The measures necessary for the implementation of this Directive should be adoptedin accordance with Council Decision 1999/468/EC of 28 June 1999 laying down theprocedures for the exercise of implementing powers conferred on the Commission(14).

(31) In order to increase the effective implementation of the provisions adopted under thisDirective it is appropriate to provide for penalties to be applied by Member States.

(32) Since the objectives of this Directive, namely to contribute to general confidence bothin the quality of donated blood and blood components and in the health protection ofdonors, to attain self-sufficiency at a Community level and to enhance confidence inthe safety of the transfusion chain among the Member States, cannot be sufficientlyachieved by the Member States and can therefore by reason of its scale and effectsbe better achieved at Community level, the Community may adopt measures, inaccordance with the principle of subsidiarity as set out in Article 5 of the Treaty. Inaccordance with the principle of proportionality, as set out in that Article, this Directivedoes not go beyond what is necessary in order to achieve those objectives.

(33) Responsibility for the organisation of health services and the provision of medical careshould remain the responsibility of each Member State,

HAVE ADOPTED THIS DIRECTIVE:

CHAPTER I

GENERAL PROVISIONS

Article 1

Objectives

This Directive lays down standards of quality and safety of human blood and of bloodcomponents, in order to ensure a high level of human health protection.

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Document Generated: 2020-12-14Status: EU Directives are being published on this site to aid cross referencing fromUK legislation. After exit day no further amendments will be applied to this version.

Article 2

Scope

1 This Directive shall apply to the collection and testing of human blood and bloodcomponents, whatever their intended purpose, and to their processing, storage, and distributionwhen intended for transfusion.

2 Where blood and blood components are collected and tested for the sole purpose andexclusive use in autologous transfusion and are clearly identified as such, the requirements to becomplied with in respect thereof shall be in accordance with those referred to in Article 29(g).

3 This Directive shall apply without prejudice to Directives 93/42/EEC(15), 95/46/EC or98/79/EC(16).

4 This Directive does not apply to blood stem cells.

Article 3

Definitions

For the purposes of this Directive:

(a) ‘blood’ shall mean whole blood collected from a donor and processed either fortransfusion or for further manufacturing;

(b) ‘blood component’ shall mean a therapeutic constituent of blood (red cells, white cells,platelets, plasma) that can be prepared by various methods;

(c) ‘blood product’ shall mean any therapeutic product derived from human blood orplasma;

(d) ‘autologous transfusion’ shall mean transfusion in which the donor and the recipientare the same person and in which pre-deposited blood and blood components are used;

(e) ‘blood establishment’ shall mean any structure or body that is responsible for anyaspect of the collection and testing of human blood or blood components, whatevertheir intended purpose, and their processing, storage, and distribution when intendedfor transfusion. This does not include hospital blood banks;

(f) ‘hospital blood bank’ shall mean a hospital unit which stores and distributes and mayperform compatibility tests on blood and blood components exclusively for use withinhospital facilities, including hospital based transfusion activities;

(g) ‘serious adverse event’ shall mean any untoward occurrence associated withthe collection, testing, processing, storage and distribution, of blood and bloodcomponents that might lead to death or life-threatening, disabling or incapacitatingconditions for patients or which results in, or prolongs, hospitalisation or morbidity;

(h) ‘serious adverse reaction’ shall mean an unintended response in donor or in patientassociated with the collection or transfusion of blood or blood components thatis fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs,hospitalisation or morbidity;

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(i) ‘blood component release’ shall mean a process which enables a blood component tobe released from a quarantine status by the use of systems and procedures to ensurethat the finished product meets its release specification;

(j) ‘deferral’ shall mean suspension of the eligibility of an individual to donate blood orblood components such suspension being either permanent or temporary;

(k) ‘distribution’ shall mean the act of delivery of blood and blood components to otherblood establishments, hospital blood banks and manufacturers of blood and plasmaderived products. It does not include the issuing of blood or blood components fortransfusion.

(l) ‘haemovigilance’ shall mean a set of organised surveillance procedures relating toserious adverse or unexpected events or reactions in donors or recipients, and theepidemiological follow-up of donors;

(m) ‘inspection’ shall mean formal and objective control according to adopted standardsto assess compliance with this Directive and other relevant legislation and to identifyproblems.

Article 4

Implementation

1 Member States shall designate the competent authority or authorities responsible forimplementing the requirements of this Directive.

2 This Directive shall not prevent a Member State from maintaining or introducing inits territory more stringent protective measures which comply with the provisions of the Treaty.

In particular, a Member State may introduce requirements for voluntary and unpaiddonations, which include the prohibition or restriction of imports of blood and bloodcomponents, to ensure a high level of health protection and to achieve the objective setout in Article 20(1), provided that the conditions of the Treaty are met.

3 In carrying out the activities covered by this Directive the Commission may haverecourse to technical and/or administrative assistance to the mutual benefit of the Commissionand of the beneficiaries, relating to identification, preparation, management, monitoring, auditand control, as well as to support expenditure.

CHAPTER II

OBLIGATIONS ON MEMBER STATES AUTHORITIES

Article 5

Designation, authorisation, accreditation or licensing of blood establishments

1 Member States shall ensure that activities relating to the collection and testing ofhuman blood and blood components, whatever their intended purpose, and to their preparation,storage, and distribution when intended for transfusion, are undertaken only by the bloodestablishments which have been designated, authorised, accredited or licensed by the competentauthority for that purpose.

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2 For the purpose of paragraph 1, the blood establishment shall submit the informationlisted in Annex I to the competent authority.

3 The competent authority, having verified whether the blood establishment complieswith the requirements set out in this Directive, shall indicate to the blood establishment whichactivities it may undertake and which conditions apply.

4 No substantial change in activities shall be undertaken by the blood establishmentwithout prior written approval by the competent authority.

5 The competent authority may suspend or revoke the designation, authorisation,accreditation or licence of a blood establishment if inspection or control measures demonstratethat the blood establishment does not comply with the requirements of this Directive.

Article 6

Hospital blood banks

Articles 7, 10, 11(1), 12(1), 14, 15, 22 and 24 shall apply to hospital blood banks.

Article 7

Provisions for existing establishments

Member States may decide to maintain national provisions for nine months after thedate laid down in Article 32 so as to enable blood establishments operating under theirlegislation to comply with the requirements of this Directive.

Article 8

Inspection and control measures

1 Member States shall ensure that the competent authority organise inspections andappropriate control measures in blood establishments to ensure that the requirements of thisDirective are complied with.

2 Inspection and control measures shall be organised by the competent authority on aregular basis. The interval between two inspections and control measures shall not exceed twoyears.

3 Such inspection and control measures shall be carried out by officials representing thecompetent authority who must be empowered to:

a inspect blood establishments as well as facilities of any third parties on its own territoryentrusted by the holder of the designation, authorisation, accreditation or licencereferred to in Article 5 with the task of carrying out evaluation and testing procedurespursuant to Article 18;

b take samples for examination and analysis;c examine any documents relating to the object of the inspection, subject to the provisions

in force in the Member States at the time of the entry into force of this Directive andwhich place restrictions on these powers with regard to the descriptions of the methodof preparation.

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4 The competent authority shall organise inspection and other control measures asappropriate in the event of any serious adverse event or reaction or suspicion thereof inaccordance with Article 15.

CHAPTER III

PROVISIONS FOR BLOOD ESTABLISHMENTS

Article 9

Responsible person

1 Blood establishments shall designate a person (responsible person), responsible for:— ensuring that every unit of blood or blood components has been collected and tested,

whatever its intended purpose, and processed, stored, and distributed, when intendedfor transfusion, in compliance with the laws in force in the Member State,

— providing information to the competent authority in the designation, authorisation,accreditation or licensing procedures as required in Article 5,

— the implementation of the requirements of Articles 10, 11, 12, 13, 14 and 15 in theblood establishment.

2 The responsible person shall fulfil the following minimum conditions of qualification:a he/she shall possess a diploma, certificate or other evidence of formal qualifications in

the field of medical or biological sciences awarded on completion of a university courseof study or a course recognised as equivalent by the Member State concerned;

b he/she shall have practical post-graduate experience in relevant areas for at least twoyears, in one or more establishments which are authorised to undertake activitiesrelated to collection and/or testing of human blood and blood components, or to theirpreparation, storage, and distribution.

3 The tasks specified in paragraph 1 may be delegated to other persons who shall bequalified by training and experience to perform such tasks.

4 Blood establishments shall notify the competent authority of the name of theresponsible person referred to in paragraph 1 and other persons referred to in paragraph 3together with information on the specific tasks for which they are responsible.

5 Where the responsible person or such other persons referred to in paragraph 3 arepermanently or temporarily replaced, the blood establishment shall provide immediately thename of the new responsible person and his or her date of commencement to the competentauthority.

Article 10

Personnel

Personnel directly involved in collection, testing, processing, storage, and distributionof human blood and blood components shall be qualified to perform those tasks and beprovided with timely, relevant and regularly updated training.

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CHAPTER IV

QUALITY MANAGEMENT

Article 11

Quality system for blood establishments

1 Member States shall take all necessary measures to ensure that each bloodestablishment establishes and maintains a quality system for blood establishments based on theprinciples of good practice.

2 The Commission shall establish the Community standards and specifications referredto in Article 29(h) for the activities relating to a quality system to be carried out by a bloodestablishment.

Article 12

Documentation

1 Member States shall take all necessary measures in order to ensure that bloodestablishments maintain documentation on operational procedures, guidelines, training andreference manuals, and reporting forms.

2 Member States shall take all necessary measures in order to ensure that access isprovided to these documents for officials entrusted with inspection and control measuresreferred to in Article 8.

Article 13

Record keeping

1 Member States shall take all necessary measures to ensure that blood establishmentsmaintain records of the information required in Annexes II and IV and under Article 29(b), (c)and (d). The records shall be kept for a minimum of 15 years.

2 The competent authority shall keep records of the data received from the bloodestablishments according to Articles 5, 7, 8, 9 and 15.

CHAPTER V

HAEMOVIGILANCE

Article 14

Traceability

1 Member States shall take all necessary measures in order to ensure that blood andblood components collected, tested, processed, stored, released and/or distributed on theirterritory can be traced from donor to recipient and vice versa.

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To this end, Member States shall ensure that blood establishments implement asystem for identification of each single blood donation and each single blood unit andcomponents thereof enabling full traceability to the donor as well as to the transfusionand the recipient thereof. The system must unmistakably identify each unique donationand type of blood component. This system shall be established in accordance with therequirements referred to in Article 29(a).

With regard to blood and blood components imported from third countries, MemberStates shall ensure that the donor identification system to be implemented by bloodestablishments permits an equivalent level of traceability.

2 Member States shall take all necessary measures in order to ensure that the systemused for the labelling of blood and blood components collected, tested, processed, stored,released and/or distributed on their territory complies with the identification system referred toin paragraph 1 and the labelling requirements listed in Annex III.

3 Data needed for full traceability in accordance with this Article shall be kept for atleast 30 years.

Article 15

Notification of serious adverse events and reactions

1 Member States shall ensure that:— any serious adverse events (accidents and errors) related to the collection, testing,

processing, storage and distribution of blood and blood components which may havean influence on their quality and safety, as well as any serious adverse reactionsobserved during or after transfusion which may be attributed to the quality and thesafety of blood and blood components are notified to the competent authority,

— blood establishments have in place a procedure accurately, efficiently and verifiably towithdraw from distribution blood or blood components associated with the notificationreferred to above.

2 These serious adverse events and reactions shall be notified in accordance with theprocedure and notification format referred to in Article 29(i).

CHAPTER VI

PROVISIONS FOR THE QUALITY AND SAFETYOF BLOOD AND BLOOD COMPONENTS

Article 16

Provision of information to prospective donors

Member States shall ensure that all prospective donors of blood or blood componentsin the Community are provided with information referred to in Article 29(b).

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Article 17

Information required from donors

Member States shall take all necessary measures to ensure that, upon agreement ofa willingness to commence the donation of blood or blood components, all donorsin the Community provide the information referred to in Article 29(c) to the bloodestablishment.

Article 18

Eligibility of donors

1 Blood establishments shall ensure that there are evaluation procedures in place for alldonors of blood and blood components and that the criteria for donation referred to in Article29(d) are met.

2 The results of the donor evaluation and testing procedures shall be documented andany relevant abnormal findings shall be reported to the donor.

Article 19

Examination of donors

An examination of the donor, including an interview, shall be carried out beforeany donation of blood or blood components. A qualified health professional shall beresponsible, in particular, for giving to and gathering from donors the information whichis necessary to assess their eligibility to donate and shall, on the basis thereof, assessthe eligibility of donors.

Article 20

Voluntary and unpaid blood donation

1 Member States shall take the necessary measures to encourage voluntary and unpaidblood donations with a view to ensuring that blood and blood components are in so far aspossible provided from such donations.

2 Member States shall submit reports to the Commission on these measures two yearsafter the entry into force of this Directive, and thereafter every three years. On the basis of thesereports the Commission shall inform the European Parliament and the Council of any necessaryfurther measure it intends to take at Community level.

Article 21

Testing of donations

Blood establishments shall ensure that each donation of blood and blood components istested in conformity with requirements listed in Annex IV.

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Member States shall ensure that blood and blood components imported into theCommunity are tested in conformity with requirements listed in Annex IV.

Article 22

Storage, transport and distribution conditions

Blood establishments shall ensure that the storage, transport and distribution conditionsof blood and blood components comply with the requirements referred to in Article29(e).

Article 23

Quality and safety requirements for blood and blood components

Blood establishments shall ensure that quality and safety requirements for blood andblood components meet the high standards in compliance with the requirements referredto in Article 29(f).

CHAPTER VII

DATA PROTECTION

Article 24

Data protection and confidentiality

Member States shall take all necessary measures to ensure that all data, including geneticinformation, collated within the scope of this Directive to which third parties have accesshave been rendered anonymous so that the donor is no longer identifiable.

For that purpose, they shall ensure:

(a) that data security measures are in place as well as safeguards against unauthorised dataadditions, deletions or modifications to donor files or deferral records, and transferof information;

(b) that procedures are in place to resolve data discrepancies;

(c) that no unauthorised disclosure of such information occurs, whilst guaranteeing thetraceability of donations.

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CHAPTER VIII

EXCHANGE OF INFORMATION, REPORTS AND PENALTIES

Article 25

Information exchange

The Commission shall hold regular meetings with the competent authorities designatedby the Member States, delegations of experts from blood establishments and otherrelevant parties to exchange information on the experience acquired with regard to theimplementation of this Directive.

Article 26

Reports

1 Member States shall send to the Commission, commencing on 31 December 2003 andevery three years thereafter, a report on the activities undertaken in relation to the provisions ofthis Directive, including an account of the measures taken in relation to inspection and control.

2 The Commission shall transmit to the European Parliament, the Council, the Economicand Social Committee and the Committee of the Regions, the reports submitted by the MemberStates on the experience gained in implementing this Directive.

3 The Commission shall transmit to the European Parliament, the Council, the Economicand Social Committee and the Committee of the Regions, commencing on 1 July 2004 and everythree years thereafter, a report on the implementation of the requirements in this Directive, andin particular those relating to inspection and control.

Article 27

Penalties

Member States shall lay down the rules on penalties applicable to infringements ofthe national provisions adopted pursuant to this Directive and shall take all measuresnecessary to ensure that they are implemented. The penalties provided for must beeffective, proportionate, and dissuasive. Member States shall notify those provisions tothe Commission by the date specified in Article 32 at the latest and shall notify it withoutdelay of any subsequent amendments affecting them.

CHAPTER IX

COMMITTEES

[F1Article 28

Committee procedure

1 The Commission shall be assisted by a Committee.

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2 Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/ECshall apply, having regard to the provisions of Article 8 thereof.

The period referred to in Article 5(6) of Decision 1999/468/EC shall be set at threemonths.

3 Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 ofDecision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4 Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.]

Textual AmendmentsF1 Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18

June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 ofthe Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutinyAdaptation to the regulatory procedure with scrutiny — Part Four.

Article 29

Technical requirements and their adaptation to technical and scientific progress

[F1The adaptation of the technical requirements set out in Annexes I to IV to technicaland scientific progress shall be decided by the Commission. Those measures, designedto amend non-essential elements of this Directive by supplementing it, shall be adoptedin accordance with the regulatory procedure with scrutiny referred to in Article 28(3).On imperative grounds of urgency, the Commission may have recourse to the urgencyprocedure referred to in Article 28(4) as regards technical requirements set out inAnnexes III and IV.]

[F1The following technical requirements and their adaptation to technical and scientificprogress shall be decided by the Commission:](a) traceability requirements;

(b) information to be provided to donors;

(c) information to be obtained from donors including the identification, health history,and the signature of the donor;

(d) requirements concerning the suitability of blood and plasma donors and the screeningof donated blood including— permanent deferral criteria and possible exemption thereto— temporary deferral criteria;

(e) storage, transport and distribution requirements;

(f) quality and safety requirements for blood and blood components;

(g) requirements applicable to autologous transfusions;

(h) Community standards and specifications relating to a quality system for bloodestablishments;

http://www.legislation.gov.uk/id/eur/2009/596




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(i) Community procedure for notifying serious adverse reactions and events andnotification format.

[F2Technical requirements referred to in points (a) to (i) of the second paragraph, beingmeasures designed to amend non-essential elements of this Directive by supplementingit, shall be adopted in accordance with the regulatory procedure with scrutiny referredto in Article 28(3).

On imperative grounds of urgency the Commission may have recourse to the urgencyprocedure referred to in Article 28(4) as regards technical requirements referred to inpoints (b), (c),(d), (e), (f) and (g) of the second paragraph.]

Textual AmendmentsF1 Substituted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18

June 2009 adapting a number of instruments subject to the procedure referred to in Article 251 ofthe Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutinyAdaptation to the regulatory procedure with scrutiny — Part Four.

F2 Inserted by Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treatyto Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny Adaptation tothe regulatory procedure with scrutiny — Part Four.

Article 30

Consultation of scientific committee(s)

The Commission may consult the relevant scientific committee(s) when establishingthe technical requirements referred to in Article 29 and when adapting the technicalrequirements set out in Annexes I to IV to scientific and technical progress, in particularwith a view to ensuring an equivalent level of quality and safety of blood and bloodcomponents used for transfusion and blood and blood components used as a startingmaterial for the manufacture of medicinal products.

CHAPTER X

FINAL PROVISIONS

Article 31

Amendment of Directive 2001/83/EC

Article 109 of Directive 2001/83/EC shall be replaced by the following:Article 109

For the collection and testing of human blood and human plasma, Directive 2002/98/EC of theEuropean Parliament and of the Council of 27 January 2003 setting standards of quality andsafety for the collection, testing, processing, storage and distribution of human blood and bloodcomponents and amending Directive 2001/83/EC(17) shall apply.









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Article 32

Transposition

1 Member States shall bring into force the laws, regulations and administrativeprovisions necessary to comply with this Directive not later than 8 February 2005. They shallforthwith inform the Commission thereof.

When Member States adopt those provisions, they shall contain a reference to thisDirective or shall be accompanied by such reference on the occasion of their officialpublication. Member States shall determine how such reference is to be made.

2 Member States shall communicate to the Commission the texts of the provisions ofnational law that they have already adopted or which they adopt in the field governed by thisDirective.

Article 33

Entry into force

This Directive shall enter into force on the day of its publication in the Official Journalof the European Union.

Article 34

Addressees

This Directive is addressed to the Member States.



ANNEX I

INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENTTO THE COMPETENT AUTHORITY FOR THE PURPOSESOF DESIGNATION, AUTHORISATION, ACCREDITATIONOR LICENSING IN ACCORDANCE WITH ARTICLE 5(2)

Part A:

General information:— identification of the blood establishment— name, qualification and contact details of responsible persons— a list of hospital blood banks which it supplies.

Part B:

A description of the quality system, to include:— documentation, such as an organisation chart, including responsibilities of responsible

persons and reporting relationships— documentation such as site master file or quality manual describing the quality system

in accordance with Article 11(1)— number and qualifications of personnel— hygiene provisions— premises and equipment— list of standard operating procedures for recruitment, retention and assessment

of donors, for processing and testing, distribution and recall of blood and bloodcomponents and for the reporting and recording of serious adverse reactions andevents.

ANNEX II

REPORT OF THE BLOOD ESTABLISHMENT'S PRECEDING YEAR'S ACTIVITY

This annual report will include:— total number of donors who give blood and blood components— total number of donations— an updated list of the hospital blood banks which it supplies— total number of whole donations not used— number of each component produced and distributed— incidence and prevalence of transfusion transmissible infectious markers in donors of

blood and blood components— number of product recalls— number of serious adverse events and reactions reported.

Directive 2002/98/EC of the European Parliament and of the Council of 27 January...Document Generated: 2020-12-14

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ANNEX III

LABELLING REQUIREMENTS

The label on the component must contain the following information:— the official name of the component— the volume or weight or number of cells in the component (as appropriate)— the unique numeric or alphanumeric donation identification— the name of producing blood establishment— the ABO Group (not required for plasma intended only for fractionation)— the Rh D Group, either Rh D positive or Rh D negative (not required for plasma

intended only for fractionation)— the date or time of expiry (as appropriate)— the temperature of storage— the name, composition and volume of anticoagulant and/or additive solution (if any).

ANNEX IV

BASIC TESTING REQUIREMENTS FORWHOLE BLOOD AND PLASMA DONATIONS

The following tests must be performed for whole blood and apheresis donations, includingautologous predeposit donations:— ABO Group (not required for plasma intended only for fractionation)— Rh D Group (not required for plasma intended only for fractionation)— testing for the following infections in the donors:

— Hepatitis B (HBs-Ag)— Hepatitis C (Anti-HCV)— HIV 1/2 (Anti-HIV 1/2)

Additional tests may be required for specific components or donors or epidemiologicalsituations.



(1) OJ C 154 E, 29.5.2001, p. 141 andOJ C 75 E, 26.3.2002, p. 104.

(2) OJ C 221, 7.8.2001, p. 106.(3) OJ C 19, 22.1.2002, p. 6.(4) Opinion of the European Parliament of 6 September 2001 (OJ C 72 E, 21.3.2002, p. 289), Council

Common Position of 14 February 2002 (OJ C 113 E, 14.5.2002, p. 93) and Decision of the EuropeanParliament of 12 June 2002 (not yet published in the Official Journal). Decision of the EuropeanParliament of 18 December 2002 and Decision of the Council of 16 December 2002.

(5) OJ L 311, 28.11.2001, p. 67.(6) OJ C 164, 30.6.1995, p. 1.(7) OJ C 374, 11.12.1996, p. 1.(8) OJ C 268, 4.10.1993, p. 29.(9) OJ C 329, 6.12.1993, p. 268.(10) OJ C 249, 25.9.1995, p. 231.(11) OJ C 141, 13.5.1996, p. 131.(12) OJ L 281, 23.11.1995, p. 31.(13) OJ L 203, 21.7.1998, p. 14.(14) OJ L 184, 17.7.1999, p. 23.(15) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993,

p. 1). Directive as last amended by Directive 2001/104/EC of the European Parliament and of theCouncil (OJ L 6, 10.1.2002, p. 50).

(16) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitrodiagnostic medical devices (OJ L 331, 7.12.1998, p. 1).

(17) OJ L 33, 8.2.2003, p. 30.’

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